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Surgical/medical respirator, single-use - ARTG 393074

Access comprehensive regulatory information for Surgical/medical respirator, single-use in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class I is registered under ARTG number 393074 and sponsored by VITRYL AUS PTY LTD, manufactured by Guangdong Kaidi Garments Co Ltd in China. The device registration started on July 29, 2022.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.

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TGA ARTG Official Data
Class I
ARTG 393074
Class I
Surgical/medical respirator, single-use
ARTG ID: 393074
Good Name: VITRYL AUS PTY LTD - Surgical/medical respirator, single-use
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Intended Purpose

This is a form-shaped filtering mask that is intended to be used to placed over the nose and mouth of a member of the general public to permit normal breathing while protecting the wearer from large particles to prevent cross contamination.

Device Classification
Risk Class
Class I
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
393074
Start Date
July 29, 2022
Effective Date
July 29, 2022
Manufacturer
Country
China
Address
Shenxiyang Industrial Zone Fengshan Street Heping Town Chaoyang, Shantou, Guangdong